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CompletedNCT03686267Updated Jun 13, 2025

Evaluation of the Aesthetic Outcome of Lithium Disilicate (e.Max) All Ceramic Crowns on Titanium Implant Abutments in the Aesthetic Zone After Different Color Masking Approaches

An interventional study of opaqued titanium abutments and lithium disilicate coping (high opacity) in Aesthetic Outcome of Crowns on Implants, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Cairo University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Implants have become the perfect solution for replacement of missing single teeth, partial or even complete edentulism.18 However, the dilemma of anterior implant-supported prosthesis is still not quite solved.19-21 Implant abutments are one of the esthetic influencers. And concerning the material, ready-made titanium abutments are considered the gold standard of all. Nevertheless, the esthetic properties remain doubtful. Lithium disilicate ceramics have been used as implant superstructures for many years now for their combined esthetic and biomechanical properties. The purpose of the present study is to evaluate the effect of using titanium implant abutment on the color of lithium disilicate crowns and the significance of masking the titanium abutments with opaque porcelain or using opaque lithium disilicate coping on the final esthetic outcome

Read the detailed description

Clinical resemblance is one the of main factors that preclude the success of any restoration. The use of conventional titanium implant abutment and ceramic restoration succeeded to prevail until now. New ceramic and polymer derivatives have been introduced such as hybrid ceramics, PEEK and PEKK. However, the low mechanical properties and the ease of breakage still limited them to certain clinical situations. Hybrid fixture-abutment combinations such as hybrid abutments and hybrid crowns proved to be highly efficient in the literature. But the technique sensitivity and the urge of high clinical and laboratory skills are obstacles that must be taken into consideration. This is the reason that finding esthetic modification of the conventional techniques seems reasonable. Masking the color of the underlying abutment appears to be a simple and easily achievable solution for having a highly esthetic implant supported prosthesis.

The importance of peri-implant soft tissues, whether esthetically or biologically, has been emphasized in literature. (4) Furthermore, achieving the desired esthetic outcome depends on simultaneously matching the proper esthetic criteria of the tooth and its supporting structures. (5) Esthetic failures in implant dentistry can be categorized as pink-tissue failures and white-tissue failures. (6) Pink esthetics include color, texture and level of peri-implant tissues (7), while white esthetics include color, shape and characterization of crown. (3) The mode of fabrication also influences the performance of the materials, where the use of press technology facilitates the construction of implant supported crowns, offering precision of fit, durability and esthetic materials application. (11)

02

Conditions studied

  • Aesthetic Outcome of Crowns on Implants

Keywords

  • implants- titanium abutments- all ceramic crowns- lithium disilicate- color measurements- pink and white aesthetics
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    1. Above 18 years old 2. Literate, capable of reading and signing the informed consent document 3. Healthy, Free from or with controlled systemic disease 4. With acceptable oral health to support implant restorations 5. With good bone quality and quantity 6. Cooperative, accepting follow up and maintenance sessions 7. Having missing tooth in esthetic zone

Exclusion criteria

Exclusion Criteria:

    1. Under 18 years old 2. Illiterate, unable of comprehending or signing the informed consent document 3. Unhealthy with uncontrolled systemic disease (e.g. Diabetes or hypertension) 4. Pregnancy 5. With unfavorable oral state that might affect implant procedure and restoration 6. Uncooperative, not willing to return for follow up visits
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    intervention (I1)

    Lithium disilicate crowns over titanium abutments covered by a layer of opaque porcelain

    Other: opaqued titanium abutments

  • Experimental
    Intervention (I2)

    Lithium disilicate crowns over titanium abutments covered by lithium disilicate (high opacity) coping

    Other: lithium disilicate coping (high opacity)

  • Active comparator
    Lithium disilicate crowns over uncovered titanium abutments

    Lithium disilicate crowns over uncovered titanium abutments directly without masking

    Other: titanium abutment with no color masking

Interventions

  • Otheropaqued titanium abutments

    masking metallic color of titanium abutments by opaque porcelain

  • Otherlithium disilicate coping (high opacity)

    masking metallic color of titanium abutments using lithium disilicate copings

    Also known as: E-max coping

  • Othertitanium abutment with no color masking

    color masking methods are avoided in this arm

06

What researchers measure

Primary outcomes

  1. Pink esthetics and White esthetics

    using numerical score (0-10) to evaluate the aesthetics of soft and hard dental tissues

    Time frame: six months

Secondary outcomes

  1. Color measurements

    using Spectrophotometer to evaluate color in terms of CIE L\* a\* b\* values

    Time frame: six months

07

Study locations

1 site
  • Faculty of Dentistry- Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03686267
Lead sponsor
Cairo University
Responsible party
Karim Ahmed Awadallah Osman (assistant lecturer- fixed prosthodontics department, Cairo University) — Principal investigator
First posted
Sep 26, 2018
Start date
Jul 25, 2019
Primary completion
Sep 3, 2020
Completion
Sep 28, 2020
Last update
Jun 13, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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